Clinical Development Consulting: 
Strategy, Plans & Operations

Challenge: A venture capital-backed platform technology company wanted to develop its internal pipeline of therapeutic candidates, while allowing prospective partners to access the technology platform through selected R&D collaborations.

Solution: Our oncology consultant created a detailed timeline and gap analysis for the company’s initial IND filing and Phase 0-l clinical trial launch, and conducted the following tasks.

• Reviewed relevant documents, including the technology, pre-existing corporate, scientific and clinical goals, and any preclinical data

• Held interviews with key stakeholders including company founders, the CEO and the internal R&D team

• Reviewed potential target cancer indications and establishing up-to-date standards of care

• Reviewed relevant biomarkers to inform PK/PD activity and patient enrichment strategies

• Prepared a clinical development plan including prioritization of target indications, design of Phase 0-lla clinical trials and proposal for clinical trial investigators and sites

• Developed an interval-to-IND filing gap analysis.

Our consultant presented to the board and was retained as an ongoing medical advisor to the company. Further case studies regarding the work Alacrita performs in clinical development are available here.

Challenge: For a European pharmaceutical company, a highly-experienced Alacrita consultant with a background in endocrine and metabolic therapies acted as medical director for the registration of a new agent in a neuroendocrine indication in territories outside the USA. Alacrita was brought in by the client five months before the planned MAA submission date after the internal medical director and other key team members unexpectedly left the company and could not be replaced internally.

Solution: During the five-month period, the team finalized the study reports, wrote the overview and the SmPC for the submission as well as preparing an ODD application (which was granted). The team received numerous questions from the rapporteur and co rapporteur and the same team worked on the responses to questions, including new statistical analyses of the clinical data. The Alacrita medic represented the company in regulatory agency meetings and the product was successfully steered through regulatory approval. Following this, submissions were prepared for other non-US territories and the dossier was transitioned to the client’s commercial team.

Challenge: A listed biotech company conducting Phase III clinical trials in an oncology indication needed Chief Medical Officer support for multiple clinical activities in Europe and the United States.

Solution: We provided medical oversight of three ongoing clinical trials, in particular, providing medical oversight for a Phase I trial and preparing for:

• marketing application
• data and safety measurement board (DSMB) review of an ongoing Phase IIb clinical trial
• launch of a Phase II clinical study in pancreatic cancer.

Challenge: A US-based cancer vaccine company developing a peptide-based product was in clinical trials in its lead indication. Recent laboratory research had revealed the target antigens were also expressed on a number of other solid tumor types, and the company wanted to assess which of those indications were the most attractive for expanding the program.

Solution: Alacrita conducted desk research and physician interviews to identify the patient populations that could be most amenable to cancer vaccine therapy and clinical development. Findings suggested that the ideal clinical trial for a cancer vaccine enrolls a group of patients that have minimal residual disease, intact immune systems and at least 18 months of expected survival. We also found a clinical planning trade-off between patient disease stage (and consequent likelihood of response to a cancer vaccine), and anticipated clinical trial duration. We identified a number of possible clinical development options that met our client’s requirements, including an exploratory clinical trial that could be conducted rapidly to provide evidence of biological activity to help justify investment in a larger, randomized clinical program.

Challenge: A European pharmaceutical company required medical, clinical and technical expertise for radoipharmaceuticals, theranostic development and medical imaging. Alacrita was engaged to provide the necessary support..

Solution: The Alacrita team provided expertise that was not available within the client organization, and support for a portfolio of molecules spanning Phase I and Phase II clinical trials was critical to the timely execution of the development plan. Alacrita provided this support over a period of three years.

The following support was provided:

• Provided strategic and scientific expertise into radiopharmaceutical and theranostic development and medical imaging
• Helped design and develop protocols/studies with imaging as a primary or secondary endpoint
• Recommended, built consensus and then designed Phase II protocol for the first multi-center study which was designed to answer the FDA pre-IND questions.
• Critically reviewed and helped design all medical imaging assessments for oncology teams across four protocols
• Evaluated the program and ROI and recommended a companion diagnostic development pathway.
• Supported the evaluation and operational management of the imaging core labs (ICL) in studies where medical imaging was being used, including careful review and editing of Imaging Charters and Image acquisition guidelines.
• Acted as interim senior clinical development leader for a Phase I trial
• Provided input to and implemented the strategic direction and tactical execution of drug development trials
• Wrote the protocols and provide insight into all the imaging endpoints.
• Developed the concept of modified Ga RECIST, modified Ga PERCIST and volumetric assessments in the protocols to ensure the theranostic approach would be fully elucidated any abscopal effects would be seen.
• Provided scientific expertise, strategic and operational input to external innovation and due diligence activities as requested.
• Supported the regulatory teams in representing the company in regulatory agency and health authority relations including:
  • Wrote the initial response to the FDA re the IND
  • Supported and wrote some of the sections for the IND
  • Developed and wrote a significant part of the questions to the FDA briefing book for the FDA to support the approach for a companion diagnostic
  • Suggested the opportunity to meet with the FDA as part of a Critical Path for Innovation meeting (CPIM) and developed the document submitted to the FDA and slides for the possible meeting.

Challenge: A venture capital-backed platform technology company wanted to develop its internal pipeline of therapeutic oncology candidates, while allowing prospective partners to access the technology platform through selected R&D collaborations. Alacrita was asked to help create a detailed early clinical plan for the company's lead asset, to be used as a foundation piece of the business strategy.

Solution:

Our oncology consultant created a detailed timeline and gap analysis for the company’s initial IND filing and Phase 0-l clinical trial launch.

This involved:

• reviewing relevant documents, including the technology, pre-existing corporate, scientific, and clinical goals, and any preclinical data
• holding interviews with key stakeholders including company founders, the CEO and the internal R&D team
• reviewing potential target cancer indications and establishing up-to-date standards of care
• reviewing relevant biomarkers to inform PK/PD activity and patient enrichment strategies
• preparing a clinical development plan including prioritization of target indications, design of Phase 0-lla clinical trials and proposal for clinical trial investigators and sites
• developing an interval-to-IND filing gap analysis.